NCT01471041已完成2 期
Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial
Vital Access Corp.4 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2011年12月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis
研究概览
简要总结
The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Deep, uncannulatable, upper extremity arteriovenous fistula
- •Minimum arteriovenous fistula flow 400 ml/min
- •One year life expectancy
排除标准
- •Non-transposed basilic or brachial vein arteriovenous fistula
- •History of peripheral vascular disease
- •History of cardiovascular disease
- •History of cerebral vascular disease
结局指标
主要结局
Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis
时间窗: 3 months
Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.
次要结局
- Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide(6 months)
研究者
研究点 (4)
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